- Category: Pharma
- Type: Permanent
- Salary: EUR 100000 to 160000 Annual
- Job Reference: JR 25637
- Consultant: email@example.com
Head of European Regulatory Affairs
If you’re a regulatory affairs expert with strong post marketing experience and you’d like to hear about a genuinely great opportunity with an established and growing niche biotechnology company in Dublin I’d love to hear from you.
Our client is a relatively new and already highly successful development and commercialisation biotech working in areas of significant unmet medical need.
With two products in the market catering to orphan / ultra orphan diseases and recent approvals for both in the EU and US they are well placed to change the lives of patients who until now have lived without hope of effectively treating their life changing diseases.
With an established presence in Europe built over the last 3-4 years they are investing in a EU HQ in Dublin where the focus is on regulatory, quality, supply chain and finance.
Reporting to the Global head / VP of Regulatory Affairs in the US, the Head of European Regulatory Affairs will be responsible for developing and implementing regulatory strategies and planning, managing and executing regulatory activities for products within Europe. There will be a strong dotted line into the EU organisation and key internal stakeholders are the Head of Europe, the VP EU Medical Affairs and country / regional cluster heads.
The role is heavily oriented towards supporting regulatory activities around their two current marketed products.
As the sole dedicated Regulatory professional in the EU organisation the role is broad. There are strong elements of both strategic and hands on work.
- Defining and driving the overall EU regulatory strategy.
- Defining and executing strategies for post-marketing regulatory submissions and required maintenance (amendments, notifications, variations, renewals, annual updates) for drug products in the EU
- Drafting EU specific documentation needed for submissions and working with external vendors to submit to Health Authorities in a timely manner
- Support the writing and review of EU SOPs and assist in inspection readiness of the EU office
- To a limited extent working with CRO and niches consultancies to manage and review customisation of CTA dossiers for pipeline products
- Serve as a liaison with the EMA for Akcea marketed products
- Educate project teams on regulatory pathways and requirements to ensure effective product development and registration
- Provide training on specific regulatory topics, as needed
Personal Characteristics / competencies required
- First and foremost a can do, results driven attitude; a genuine focus on getting great solutions in place.
- A strong compliance mindset married to an ability to work pragmatically and align with the overall commercial strategy.
- Creativity in defining and driving novel strategies and solutions to operational challenges.
- Strong leadership skills; having the ability to motivate and draw along colleague and external suppliers.
- An ability to think and act both strategically and operationally.
- A strong track record of success in post marketing regulatory affairs roles.
- While strong candidates with a life science degree level education would be considered it is expected that a relevant post graduate qualification (PhD, Pharmacist, potentially medical) would be of benefit.
- Proven ability to cover the full span of post marketing regulatory activities at a European level.
- Extensive experience of working with EU regulatory bodies.
- Experience with rare diseases / niche therapeutics / orphan designated products would be a great asset but would not be required.
- It is not expected that a background purely focused on generic products or medical devices would offer the experience required.
- Knowledge of EU expedited programs
- Regulatory project management experience
- Strong ability to provide leadership and direction to vendors / aligned service providers.
What’s on offer
Aside from a great remuneration package our client offers an incredible opportunity to join a highly successful and growing organisation that is having a transformative effect on the lives of patients and their families.
The role has great scope to grow with the business and it is expected that the person taking this role will have a strategy for growing the regulatory function in Europe in time as more products are launched and more regulatory activity is brought in house.
You’d be joining a fantastic team of driven, ethical and engaging people who share a passion for the business and what they’re doing for their patients.
Email a word formatted CV to firstname.lastname@example.org and I will contact you.
How to apply
If this position is of interest please send us your CV here, or you can call Jack Relfe direct on 01892 507 134 to discuss this and other vacancies that may suit.